Kornimate/medical-research-clean huggingface dataset:
hippocampus dbs in treatment-resistant schizophrenia

Conditions: Treatment-resistant Schizophrenia

Summary: the goal of this clinical trial is to assess the efficacy and safety of hippocampus-targeted deep brain stimulation (dbs) in treatment-resistant schizophrenia. the main question it aims to answer are: * whether patients with treatment-resistant schizophrenia can benefit from hippocampus-targeted dbs; * what is the neural and electrophysiological mechanism underlying the treatment effect of hippocampus-targeted dbs.

the first phase of the study will consist of dbs surgery. participants will receive electrodes implantation in bilateral ventral hippocampus. continuous stimulation will be applied to optimize and individualize the stimulus parameters. this period is anticipated between 3 and 6 months. the next phase will consist of the crossover study. patients who respond to dbs will be randomly assigned to two groups, for a period of 3 months: on stimulation group and off stimulation group. patients will then be crossed over to the other group for a further 3 months. participants will receive pet-ct, clinical assessment and cognitive tests at the main study points to evaluate treatment efficacy and patient tolerance, and to reveal the underlying mechanism of the treatment effect of dbs.

Eligibility criteria:
inclusion criteria: * male or female aged between 18 and 55 years. * having a diagnosis of schizophrenia according to dsm-iv criteria * having a chronic, recurrent course of disease with a five-year minimum duration * determined to be treatment-resistant as demonstrated by: 1. persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years. 2. inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks. 3. inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects. 4. presence of persistent positive symptom defined as i) requiring a score of 4 (moderate) or more on at least 2 of the next panss items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above panss items. * maintaining stable pharmacological treatment for two months preceding screening visit. * informed consent exclusion criteria: * neurological disease * severe physical illness * contraindications to neurosurgery, mri or pet-ct; * substance abuse or dependence * mental retardation * female patients who are pregnant or breastfeeding * severe suicide risk and tendencies
robot based gait training therapy for pediatric population with cerebral palsy using the cpwalker

Conditions: Cerebral Palsy

Summary: this trial is being conducted to determine if the cpwalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy

objectives: 1. to determine the use of the cpwalker rehabilitation platform, a robotic device composed by an exoskeleton linked to a walker that provides support and balance, as a gait training intervention in the pediatric cerebral palsy population. 2. to create and define detailed guidelines consisting of robotic based treatment methods for gait rehabilitation. hypothesis: 1. cpwalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy 2. performing lower limb training in conjunction with active head and trunk control therapies will improve functional gait levels 3. following 16-24 cpwalker training sessions, persons with cerebral palsy will show improvements in functional mobility when comparing pre-training measurements to post-training measurements procedures: participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. percentage range of motion (rom), partial body weight support (pwbs), and gait velocity are the principal parameters under variation during training. additionally, screening, baseline and post-training testing sessions will be conducted

Eligibility criteria:
inclusion criteria: * diagnosis of cerebral palsy with spastic diplegia * gross motor function classification system score of 2-4 * age 11-21 at time of enrollment * maximum weight of 75kg * height range of approximately 110cm to 170cm * ability to understand and follow verbal cues * lower limb measurements meet specifications of cpwalker * cognition sufficient to communicate pain or discomfort and follow one step direction from the investigator exclusion criteria: * any orthopedic surgeries less than 3 months prior to study enrollment or ongoing botox injections * severe musculoskeletal deformities affecting safe and comfortable fit into the exoskeleton as determined by the investigator. patients may be able to wear their afos in the cpwalker if it allows for safe fit. * unhealed wounds/lesions * critical motor control alterations such as dystonia, choreoathetosis, or ataxia * aggressive or self-harming behavior * severe cognitive impairments that prevent a subject from being able to understand the exercises an/or interact with the study staff
severe head trauma: coagulation and ct-scan aggravation.

Conditions: Head Trauma

Summary: retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between january 2016 and december 2018.

the objective of the study is to describe the evolution of ctscan lesions in patients with isolated head trauma between admission and re-evaluation after 24 hours.

Eligibility criteria:
inclusion criteria: * adults * patients informed and did not object to the collection of their medical data for the study * patient admitted in trauma center between january 2016 and december 2018 severe head injury defined by a glasgow coma scale (gcs) \ 1.25) exclusion criteria: * abbreviated injury score (ais) head and neck ≤ 3 and/or ais out of head and neck \> 3 * taking drugs that interfere with hemostasis, such as anticoagulant or antiplatelet antiaggregants in preventive or curative doses; * patients under guardianship * patients still alive at the time of data collection and opposed to the collection of their data
ketamine for major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with major depressive disorder (mdd) and explore the anti-depressive effects of ketamine delivered by transdermal patch.

shx-c301 is a phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (pk), safety and antidepressant effects of shx-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose pk in subjects with mdd and sub-optimally controlled by standard of care.

Eligibility criteria:
inclusion criteria: * present a current depressive episode of at least 8 weeks * have a body mass index (bmi) of 18-35 kg/m2 (inclusive) at screening * agree to use adequate methods of contraception during the study (and for x days after discharge) exclusion criteria: * a history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry. * use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant. * treatment with any investigational drug, use of any known cyp3a4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, st. john's wort) or herbal supplements within 7 days prior to the first dose of study medication * a history of drug abuse or dependence within 180 days of screening * a febrile illness within 5 days prior to the first dose of study medication. * a known hypersensitivity to ketamine * a history of use ketamine for major depressive disorder and did not respond to ketamine * recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)

Keywords: depression
study investigating pk, pd, efficacy, safety, and immunogenicity of biosimilar denosumab (gp2411) in patients with postmenopausal osteoporosis

Conditions: Postmenopausal Women With Osteoporosis

Summary: this study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (pk), pharmacodynamics (pd), efficacy, safety, or immunogenicity between gp2411 (proposed biosimilar denosumab) and eu-authorized prolia® (denosumab).

this was an international, multicenter, randomized, double-blind, parallel-group study with a total duration of up to 83 weeks. the study comprised a screening period of up to 5 weeks to assess a subject's eligibility and two treatment periods: treatment period 1 (tp1) from day 1 to week 52 and treatment period 2 (tp2) from week 52 to week 78. women with postmenopausal osteoporosis (pmo) were randomized on day 1 in a 1:1 ratio to receive either two 60 mg subcutaneous (s.c.) doses at 26-week intervals of gp2411 (proposed biosimilar denosumab) or eu-prolia (eu-authorized prolia®) during tp1. at week 52, participants in the eu-prolia group were re-randomized 1:1 to either continue with a third dose of eu-prolia or switch to gp2411 for tp2. participants in the gp2411 group continued the treatment with a third dose of gp2411 in tp2. the end of study was achieved at week 78.

Eligibility criteria:
inclusion criteria: * postmenopausal women, diagnosed with osteoporosis * aged ≥ 55 and ≤ 80 years at screening * body weight ≥ 50 kg and ≤ 90 kg at screening * absolute bone mineral density consistent with t-score ≤ -2.5 and ≥ -4.0 at the lumbar spine as measured by dxa * at least two vertebrae in the l1-l4 region and at least one hip joint are evaluable by dxa exclusion criteria: * previous exposure to denosumab (prolia, xgeva, or biosimilar denosumab) * history and/or presence of one severe or more than two moderate vertebral fractures or hip fracture * history and/or presence of bone metastases, bone disease or metabolic disease * ongoing use of any osteoporosis treatment or use of prohibited treatment * other bone active drugs * history and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia

Keywords: prolia gp2411 denosumab postmenopausal osteoporosis
turkish version of back pain knowledge and beliefs survey

Conditions: Back Pain; Knowledge; Beliefs; Translation, Cultural Adaptation and Turkish Validation

Summary: low back pain (lbp) is a globally prevalent health issue, affecting the majority of individuals at some point in their lives. misconceptions about lbp can prolong its chronicity, highlighting the importance of educating patients with accurate information. the back pain knowledge and beliefs survey (backs), introduced in 2024, aims to measure individuals' knowledge about lbp based on updated scientific evidence. given the high prevalence of lbp in turkey and the lack of validated tools in turkish, adapting backs to turkish is essential. this study aims to conduct its cross-cultural adaptation, validation, and reliability analysis for clinical and community use.

low back pain (lbp) is one of the most prevalent health issues worldwide, with approximately three-quarters of individuals experiencing this condition at some point in their lives. misconceptions, beliefs, and misinformation about lbp can prolong the duration of pain and contribute to its chronicity. clinical guidelines emphasize the importance of educating patients with evidence-based information to remove potential barriers to recovery. the back pain knowledge and beliefs survey (backs) was introduced in october 2024 to assess individuals' knowledge and beliefs about lbp based on the most recent scientific evidence. several tools in the literature aim to measure knowledge and beliefs related to lbp, including the back beliefs questionnaire (bbq) and the back pain knowledge questionnaire. however, these tools were developed in previous decades and may not reflect the current scientific literature. additionally, the turkish versions of some of these questionnaires have not yet undergone validation and reliability studies. according to the 2016-2022 turkish health survey conducted by the turkish statistical institute (tüi̇k), back-related problems rank first among all reported health issues, with a prevalence rate of 24.6%. despite the high prevalence of lbp in turkey, there is currently no systematically validated tool available in turkish to measure the public's knowledge and beliefs regarding this condition. the adaptation of backs into turkish will help address this gap by providing a valid and reliable tool for both clinical and community-based research. measuring and evaluating patient-reported outcomes accurately is crucial in managing lbp effectively. therefore, the aim of this study is to conduct the cross-cultural adaptation, validation, and reliability analysis of the turkish version of backs.

Eligibility criteria:
inclusion criteria: * having low back pain or having a history of low back pain in the last 12 months * to be able to read and write turkish exclusion criteria: * having cognitive impairment that prevents communication * pregnancy * malignite * infections * fractures, * inflammatory diseases
nexium capsules non-steroidal anti-inflammatory drug (nsaid) specific clinical experience investigation

Conditions: Gastric Ulcer; Duodenal Ulcer

Summary: the purpose of this investigation is to collect following data in patients given nexium capsule (nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with non-steroidal anti-inflammatory drug (nsaid).

nexium capsules specific clinical experience investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with nsaids

Eligibility criteria:
inclusion criteria: -patients who are given nsaids for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given nexium to suppress recurrence of gastric ulcer or duodenal ulcer. exclusion criteria: * patients having gastric ulcer/duodenal ulcer when nexium is started (active phase (a1, a2) or healing phase (h1, h2) of sakita-miwa classification on endoscopy) * patients who had been given nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.

Keywords: nsaids gastric ulcer or duodenal ulcer nexium
environmental triggers of cardiometabolic disease

Conditions: Metabolic Syndrome X

Summary: the investigators posit that a multi-national collaborative effort with focused investigations in environments with the highest levels of exposure (developing countries such as china and india), are likely to provide new and much needed data on the risk posed by these variables on an individuals life-time risk for type 2 diabetes and cardiovascular complications. the investigators will test this hypothesis through the establishment of a network that would lead studies on the links between exposure and adverse chronic cardiometabolic effects and propose doing this in this as part of 3 specific aims.

in aim 1, the investigators propose to establish feasibility of such an effort in beijing, china, an effort that will involve implementation of novel exposure assessment methodologies simultaneously with the ability to execute key surrogate outcome measures of importance in cardiovascular risk with cm diseases. in aim 2, the association between functional cardiovascular risk variables \[insulin sensitivity, blood pressure, endothelial function\] and acute and sub-acute variations in personal black carbon and ambient particulate matter 2.5 levels among 50 individuals with the chronic cardiometabolic syndrome will be investigated. in aim 3, the investigators will examine potential biologic pathways of importance in the proposed functional outcomes. specifically the investigators will determine the association between ambient particulate matter 2.5 levels and alterations in adipocytokines/inflammatory variables and autonomic nervous system balance.

Eligibility criteria:
inclusion criteria: * nonsmokers, 35-65 years living in a nonsmoking household. * cm will be defined by idf criteria (http://www.idf.org) specific for asians \[waist circumference \>90 cm in males and 80 cm in females) plus any two of the following four factors: tg level: \>150 mg/dl, hdl: \ 130, fasting plasma glucose \> 100 mg/dl or previously diagnosed type 2 diabetes. exclusion criteria: * any active smoking within past 1 year, occupational exposures to pollutants (per discretion of investigators), self-reported daily secondhand smoke exposure \> 1 hour long (workplace or home), * history of any cv disease (e.g. previous myocardial infarction), or overt type 2 diabetes. * fasting glucose \> 126 mg/dl or a screening bp is \>160/100 mm hg. * patients cannot be taking any anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that can alter baseline insulin sensitivity, bp, or endothelial function (e.g. anti-oxidants, multi-vitamins, folic acid, fish oil supplementation, l-arginine), * daily use of nsaids is not allowed; however intermittent prn usage is acceptable. in the course of the year should a subject develop any of exclusion criteria they will be allowed to complete the study and the potential confounding effects will be assessed in statistical analyses.

Keywords: cardiometabolic disease
magnesium and rotational thromboelastometry (rotem) in colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: magnesium sulphate is given to the patients during the colorectal cancer surgery under the hypothesis that it would attenuate the postoperative hypercoagulability. the investigators intend to characterize the changes of coagulation in colorectal cancer patients by using the point-of-care device after the infusion of magnesium sulphate.


Eligibility criteria:
inclusion criteria: * the patients undergoing a laparoscopic colorectal cancer surgery exclusion criteria: * renal disease * hepatic disease * neuromuscular disease * coagulation disorder * cardiopulmonary disease
effect of pressure support ventilation and neurally adjusted ventilatory assist (nava) in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the investigators' aim is to study the effect of pressure support ventilation at two levels of peep and pressure support versus neurally adjusted ventilatory assist (nava) in copd patients.

in this study, two levels of pressure support and peep during pressure support ventilation are compared with neurally adjusted ventilatory assist (nava) in copd patients by measuring respiratory mechanics, intrinsic peep, work of breathing and patient's level of comfort.

Eligibility criteria:
inclusion criteria: * stable copd patients during non invasive mechanical ventilation exclusion criteria: * haemodynamic instability * coma

Keywords: gas exchange pressure support ventilation respiratory mechanics copd nava
impact of advanced practical nursing intervention versus usual care on hypertension control

Conditions: Hypertension

Summary: hypertension is the most frequent chronic pathology in france and in the world. it is one of the main modifiable cardiovascular risk factors. in france, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. since 2018, a new profession has entered the french healthcare system: advanced practice nurses (apn). they have many broad skills, at the interface of nursing and medical exercises. the purpose of this interventional study is to assess the impact of apn on blood pressure (bp) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. the hypothesis formulated is that an individual apn intervention, included in a usual hypertension management, improves bp control.

this study will be a prospective, open-label, randomized 1-to-1 and monocentric trial, conducted at the diagnosis and therapeutic center of the hôtel-dieu university hospital, assistance publique - hôpitaux de paris, france. recruitment will be conducted during the ambulatory hospitalization. after the signature of the consent form, the randomization will be conducted during the ambulatory hospitalization. all recruited patients will be randomized. according to the randomization, the odd-numbered participants will constitute the "usual care" group, and the even-numbered patients will constitute the "intervention" group. the "usual care" group will keep a traditional follow-up: ambulatory hospitalization then consultation with a md within approximately 2 to 12 months. the "intervention" group will meet the apn between the ambulatory hospitalization and the md consultation, within 1 to 6 months. the participants will get their study appointment(s) (md consultation +/- apn intervention) at the end of the ambulatory hospitalization according to their allocation.

Eligibility criteria:
inclusion criteria: * at least 18 years of age, * essential hypertension * hypertension management in hôtel-dieu hospital * ability to provide a written informed consent. exclusion criteria: * have already benefited from an apn follow-up before the day of inclusion * being under guardianship or curatorship * pregnant patient * beneficiary of the ame (state medical aid)

Keywords: advanced practice nurse hypertension therapeutic adherence trial
a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hrs-4729 injection in healthy subjects

Conditions: Overweight or Obesity

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of hrs-4729 injection in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. voluntarily provides written informed consent prior to the initiation of any study-related activities and demonstrates understanding of the procedures and methods involved in the study, agreeing to adhere strictly to the clinical trial protocol to complete the study. 2. male or female subjects; aged 18 to 55 years. 3. self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit). exclusion criteria: 1. a history of current significant disease in the neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, genitourinary, endocrine, hematologic, or immune systems, as determined by the investigator, which would render the subject unsuitable for participation in this trial. 2. a history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery. 3. subjects who have had a major surgery or severe trauma within 6 months prior to screening, or who are planned for surgical procedures during the trial period. 4. participation in any drug or medical device clinical trial within 3 months prior to screening. 5. any abnormal physical examination, vital signs, laboratory tests, chest x-ray and abdominal ultrasound findings deemed clinically significant by the investigator, rendering the subject unsuitable for participation. 6. clinically significant abnormalities on 12-lead ecg as determined by the investigator. 7. known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.